NCT06124872

Brief Summary

The goal of this observational study is to learn about how snakebite risk varies in different environments in Kenya and understand how this information can be used to support decision makers. The main questions it aims to answer are:

  1. 1.To what extent can information on snakebite cases and data on geographic, climatic and sociodemographic factors be used to predict geographical variation in snakebite risk in Kenya and Eswatini?
  2. 2.What is the most effective means of presenting outputs from spatial analysis of snakebite risk to ensure its effective use in research and healthcare decision making?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 9, 2023

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

May 3, 2023

Last Update Submit

November 6, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Geostatistical model of snakebite risk in Kenya and Eswatini

    A geostatistical model of snakebite risk, detailing the statistical association between selected covariates and snakebite risk, based on analysis of data on snakebite incidence collected from contrasting locations in Kenya and Eswatini.

    Through study completion, estimated end of 2024

  • An assessment of the accuracy of snakebite incidence data reported from routine surveillance systems relative to community survey estimates

    An assessment of the accuracy of routine surveillance data sources in relation to community survey incidence estimates (the gold standard measure) in each study location.

    Through study completion, estimated end of 2024

  • Recommendations

    A thematic analysis of key informant interviews on the potential role of and key features needed in snakebite risk maps in order for them to provide utility in healthcare decision making and a set of recommendations to guide presentation of spatial outputs on snakebite risk.

    Through study completion, estimated end of 2024

Study Arms (4)

Community survey 1 (planned demographic/health survey)

Households included in a planned demographic and health survey (DSS). All participants included in this survey will be invited to respond to snakebite questions.

Other: Survey questionnaire

Community survey 2 (Stand alone survey)

25 households randomly selected for inclusion within each survey cluster. Survey clusters will be randomly selected enumeration units within study Counties.

Other: Survey questionnaire

Community survey 3 (Stand alone survey)

25 households randomly selected for inclusion within each survey cluster. Survey clusters will be randomly selected enumeration units within study Counties.

Other: Survey questionnaire

Key informant interviews

Stakeholders in the process of healthcare decision making and research relevant to snakebite and snakebite envenoming

Other: Key informant interview

Interventions

Household screening questionnaire Snakebite details questionnaire where a history of snakebite is reported

Community survey 1 (planned demographic/health survey)Community survey 2 (Stand alone survey)Community survey 3 (Stand alone survey)

Semi-structured interview with selected key informants

Key informant interviews

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community surveys * Populations resident within selected counties. Key informant interviews: * Those with power and/or influence in healthcare decision making or research with relation to Neglected Tropical Diseases/snakebite.

You may qualify if:

  • Household Screening Questionnaire:
  • All heads of household from randomly selected households.
  • To account for all household members
  • Snakebite Details Questionnaire:
  • All household members with a history of snakebite. If the household member is deceased, a responsible adult from the household will be asked to complete the questionnaire.
  • Key informant interviews:
  • Key informants identified through a stakeholder mapping exercise as having power and/or influence in healthcare decision making or research with relation to Neglected Tropical Diseases/snakebite.
  • Willing and motivated to be interviewed

You may not qualify if:

  • Household Screening Questionnaire:
  • Households where the household head/a responsible adult is not present at first visit or revisit.
  • Household where the household head/responsible adult is unable or unwilling to give consent
  • Snakebite Details Questionnaire:
  • The household member is unable/unwilling to give consent and (in the case of the former) there is no responsible adult available/willing to complete the questionnaire on their behalf
  • Key informant interviews:
  • A participant whose role and organisation has already been represented in the key informant interviews
  • Participant declines to be interviewed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KSRIC

Nairobi, Kenya

Location

MeSH Terms

Conditions

Snake Bites

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Collinson

    Liverpool School of Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

November 9, 2023

Study Start

June 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 9, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Anonymised quantitative datasets (excluding household GPS) and the R code used for analysis will be made available.

Shared Documents
ANALYTIC CODE
Time Frame
following study completion and publication of key study outputs

Locations